Manufacturing Associate, Purification

Avid Bioservices, Inc.

The Manufacturing Associate – Purification performs cGMP purification operations in Avid’s Manufacturing Group. As part of the purification team, this position is responsible for all downstream procedures, from protein recovery to product filling.  

Primary Responsibilities

·       Antibody and enzyme purification via Affinity Chromatography, Size Exclusion Chromatography, Ion Exchange Chromatography, Hydrophobic Interaction and Tangential Flow Filtration.

·       Product Filtration (Sterile Filtration, Ultra Filtration, Viral Filtration)

·       Product Filling (Aseptic Processing)

·       Ensure equipment and materials are in place as required for each production run.

·       Plan and prepare needs for processes and activities.

·       Operate and maintain Bioprocess chromatography skid.

·       Pack, unpack, and clean Production Scale chromatography columns.

·       Maintain Cleanroom Facility and Equipment

·       Control and Track Raw Material Inventory

·       GMP Documentation

·       Revise and Initiate Batch Production Records, Standard Operating Procedures, Study Protocols and Reports.

Secondary Responsibilities

       Prepare Media and Buffers

·       Manually clean small parts and equipment

·       Operate Sartocheck 3 Filter Integrity Tester

·       Assist with Cell Culture (thaw, expansion, and maintenance)

·       Operate and Maintain Getinge Autoclave (19 cu ft)

·       Operate and Maintain Gruenberg Oven (15 cu ft)

·       Perform daily monitoring of equipment

·       Prepare Glassware and Equipment for Production

Qualifications

Bachelor’s degree (B.A.) or equivalent from four-year college or university plus three years related experience and/or training; or equivalent combination of education and experience. Minimum of 2 years of industry experience working with HPLC, large scale liquid chromatography columns or similar equipment.  Must also have experience with a GMP production environment, aseptic technique and working in a cleanroom environment requiring appropriate cleanroom gowning.

Language Skills

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization.

Mathematical Skills

Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.  Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

To perform this job successfully, an individual should have knowledge of computers, word processing, spreadsheet, and internet software. Microsoft Office experience highly preferred.

Other Requirements

Work overtime and weekends as necessary.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job. 

While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands to finger, handle or feel, or reach with hands and arms. The employee is frequently required to stand and walk.  The employee is occasionally required to climb or balance, stoop, kneel, crouch or crawl.  The employee must regularly lift up to 30 pounds, and occasionally lift and/or move more than 30 pounds which includes occasionally pushing 400L tanks. Specific vision abilities required by this job include Close vision, Distance vision, Color vision, Peripheral vision, Depth perception and Ability to adjust focus.

Must be able to gown for a class 10,000 cleanroom environment and work in a class 100 hood.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to risk of electrical shock; toxic or caustic chemicals; and wet or humid conditions (non-weather). The employee frequently works near moving mechanical parts.  The noise level in the work environment is usually loud.

Application Procedure:

Contact Human Resources for the complete Job Description and Internal application procedure.

External candidates should send a current resume with cover letter or completed employment application (see attached), and include salary requirements, Job Code MAP306 and the name of the Avid or Peregrine employee contact to jobline@peregrineinc.com or FAX to: 714-439-1300.